11836 Federal Register / Vol. 89, No. 32 / Thursday, February 15, 2024 / Notices 

Authority: The CAPTA 

Reauthorization Act of 2010; Title II of 

the CAPTA, Pub. L. 115–271 (42 U.S.C. 

5116 et seq.). 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–03107 Filed 2–14–24; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0447] 

Charging for Investigational Drugs 

Under an Investigational New Drug 

Application: Questions and Answers; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘Charging 

for Investigational Drugs Under an IND: 

Questions and Answers.’’ This guidance 

addresses frequently asked questions 

related to the implementation of FDA’s 

regulation on charging for 

investigational drugs under an 

investigational new drug application 

(IND) for the purpose of either clinical 

trials or expanded access for treatment 

use. This guidance finalizes the revised 

draft guidance of the same title issued 

on August 23, 2022, and replaces the 

final guidance issued on June 3, 2016. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on February 15, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2013–D–0447 for ‘‘Charging for 

Investigational Drugs Under an IND: 

Questions and Answers’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: Dat 

Doan, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 3334, Silver Spring, 

MD 20993–0002, 240–402–8926, 

Dat.Doan@fda.hhs.gov; or James Myers, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Charging for Investigational Drugs 

Under an IND: Questions and Answers.’’ 

FDA’s regulation on charging for 

investigational drugs under an IND (21 

CFR 312.8) for the purpose of either 

clinical trials or expanded access for 

treatment use allows sponsors to charge 

for investigational drugs under certain 

circumstances. 

FDA issued a final guidance on June 

3, 2016 entitled ‘‘Charging for 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 32 / Thursday, February 15, 2024 / Notices 11837 

Investigational Drugs Under an IND: 

Questions and Answers.’’ FDA issued a 

revised draft guidance of the same title 

in August 2022 to include responses to 

stakeholder questions received since 

publication of the final guidance in 

2016. This guidance finalizes the 

revised draft guidance issued on August 

23, 2022 (87 FR 51679). FDA considered 

comments received on the revised draft 

guidance as the guidance was finalized. 

Changes from the revised draft to the 

final guidance address the inclusion of 

information about charging for 

investigational drugs in the informed 

consent document and provide the 

definition of intermediate-size patient 

population expanded access. In 

addition, editorial changes were made 

to improve clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Charging for 

Investigational Drugs Under an IND: 

Questions and Answers.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://

www.regulations.gov. 

Dated: February 12, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03186 Filed 2–14–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA), Office of the 

Commissioner (OC), Office of Digital 

Transformation (ODT) has modified 

their organizational structure. The new 

organizational structure was approved 

by the Secretary of Health and Human 

Services on December 21, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Yashika Rahaman, Director, Office of 

Planning, Evaluation and Risk 

Management; Office of Finance, Budget, 

Acquisitions, and Planning; 4041 

Powder Mill Road, Beltsville, MD 

20705–4304; 301–796–3843. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

Part D, Chapter D–B, (Food and Drug 

Administration), the Statement of 

Organization, Functions and 

Delegations of Authority for the 

Department of Health and Human 

Services (35 FR 3685, February 25, 

1970, 60 FR 56606, November 9, 1995, 

64 FR 36361, July 6, 1999, 72 FR 50112, 

August 30, 2007, 74 FR 41713, August 

18, 2009, 76 FR 45270, July 28, 2011, 

and 84 FR 22854, May 20, 2019) is 

revised to reflect the FDA, OC’s ODT. 

The proposed changes to ODT’s 

organizational structure consolidate 

similar functions and resources across 

multiple areas and align the 

organizational structure with federal 

and industry standards. This will create 

a more agile organization, improve 

resource management, enhance 

customer service, and better align the 

name of organizational components 

with current functions. The 

reorganization will maintain a 

reasonable span of control and clear and 

appropriate lines of authority and 

responsibilities between organizations. 

This will also ensure optimal resource 

utilization and leveraging of existing 

staff talent and will allow ODT more 

efficiency and effectiveness in the 

advancement of continuous 

improvement efforts. 

This reorganization elevates the 

functions and resources of the Office of 

Enterprise Portfolio Management in the 

Office of Information Management and 

Technology (OIMT) to the Office of 

Digital Transformation; established the 

Division of Acquisition Innovation, 

Division of Technology Business 

Management, and the Division of 

Finance and Budget within OEPM; and 

realigned the Delivery Management 

Support Staff from the Office of 

Technology and Delivery (OTD) to 

OEPM, Division of Acquisition 

Innovation; established the Acquisitions 

Operations Branch, Acquisition 

Governance Branch, and IT Asset 

Management Branch within the Division 

of Acquisition Innovation; established 

the IT Governance Branch and Business 

Intelligence Branch within the Division 

of Technology Business Management; 

establish the Budget Formulation 

Branch and Budget Execution Branch 

within the Division of Finance and 

Budget; established the Office of 

Organizational Excellence (OEX) 

reporting to the ODT; established the 

Division of People and Culture (DPC) 

and the Division of Knowledge and 

Communications (DKC) within OEX; 

realigned the staff resources and 

functions from the OBCA Division of 

Management Services (DMS) to DPC in 

OEX; established the Talent Strategy 

Staff (TSS) and the Executive Services 

Staff (ESS) within OEX; abolished the 

Strategic Operations Staff (SOS) located 

in ODT Immediate Office and realigned 

staff resources and functions to DKC in 

OEX; realigned staff resources and 

functions from the Knowledge 

Management Staff (KMS) in the Office of 

Data, Analytics, and Research to DKC; 

realigned existing executive services 

functions and staff in the ODAR, OIMT, 

and ODT immediate offices to DKC; 

retitled the current Office of Business 

and Customer Assurance in OIMT to the 

Office of Customer Experience (OCX); 

abolished the Division of Management 

Services and Division of Business 

Partnerships and Support in the current 

Office of Business and Customer 

Assurance; established the Division of 

Collaboration Services, Division of 

Service Desk and Support, Division of 

Endpoint Management, Division of End 

User Services, and Division of Employee 

Information in the new OCX; 

established the Enterprise Architecture 

Staff in the OIMT Immediate Office; 

established the Division of Engineering 

(DE) in the OIMT Office of Technology 

and Delivery; established the 

Engineering Branch, Implementation 

Branch, Application Branch, and 

Database & Content Services Branch 

within DE; retitled the Division of 

Infrastructure Operations (DIO) in the 

OTD in OIMT to the Division of 

Infrastructure Services (DIS); abolished 

the Infrastructure Management Services 

Staff (IMSS) within DIO and realigned 


khammond on DSKJM1Z7X2PROD with NOTICES